The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus…
The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool. The instrument is an accessory to the Fiagon navigation system. It is designed to be used with the Fiagon Navigation system and with XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool. The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by Entellus Medical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions for use.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Guidewire 0.6 Single Use | Listed by | Fiagon GMBH, Germany |
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| Record published | 2017-11-23 |
| Record revised | 2024-09-10 (version 7) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 35 °C; Handling environment humidity 30 to 75 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Sizes | Length 278 mm; outer diameter 0.6 mm |
| Distribution end date | 2024-09-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.